Suicidality and Suicide Attempt Among HIV Patients on Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens

HIV Infection Clinical Trial

Official title:

The Risk of Suicidality and Suicide Attempt Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211807
• Other study ID #: AI266-960
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: October 14, 2014
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to compare the frequency of suicidality and suicide attempt among HIV patients starting treatment with Efavirenz and with patients starting treatment with other HIV medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11400
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• At least 6 months of enrollment before first prescription

• Antiretroviral naive

Exclusion Criteria:

• No diagnosis of HIV on patient record

• Age < 12 years

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV Infection
• Suicide, Attempted

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Truven Health Analytics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases of Suicidality, defined as suicidal ideation and suicide attempt		Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period	Yes
Secondary	Number of suicide attempt cases, defined as an inpatient or emergency room claim with at least one ICD-9-CM code for suicide attempt		Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period	Yes
Secondary	Number of suicide attempt cases	Expanded definition, defined as an inpatient of emergency department claim for suicidal attempt or a claim for toxic effects of poisoning, open wound to elbow, wrist or forearm, of asphyxiation plus a diagnosis of psychiatric disorders	Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form